Elranatamab in Patients With Relapsed or Refractory AL Amyloidosis
ConditionAL Amyloidosis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
This study will evaluate the safety, tolerability and efficacy of elranatamab in patients with relapsed or refractory AL amyloidosis.
Eligibility criteria
Qualifiers
Previously diagnosed with AL amyloidosis based on IMWG criteria who have relapsed or refractory disease after treatment with at least one prior line of therapy (minimum 2 cycles).
Participants must have progression of light chain disease, defined as dFLC >20mg/L.
For Phase 2 only, measurable hematologic disease, satisfying one of the following criteria: Difference between involved and uninvolved free light chain (FLC) over 40 mg/L; Abnormal level of FLC with an abnormal κ/λ ratio (except in participants with CKD stage 3 or higher where a rise of lambda FLC to an abnormal level and of at least 50% over the nadir with a normal κ/λ ratio is acceptable); A serum M spike measuring ≥ 0.5 g/dL
Age ≥ 18 years
Disqualifiers
Prior BCMA-targeting bispecific antibodies or BCMA-targeting CAR-T therapy.
Participants refractory to belantamab mafodotin OR participants that have received belantamab as the immediate past line of therapy.
Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
Participants who are receiving any other investigational agents for this condition.
Trial design
Treatments tested in this trial
- Elranatamab
Treatment groups
49 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov